Cassava Sciences update: SAVA’s stock price falls after Alzheimer’s drug decline

In March, pharmaceutical company Cassava Sciences made headlines in a Food and Drug Administration (FDA) report that cast doubt on positive research results for its novel Alzheimer’s drug, simufilam.

Then in September, the Securities and Exchange Commission (SEC) settled with Cassava on charges that the company misled investors about the effectiveness of its new drug.

And today, Cassava announced that its Phase 3 trials of simufilam failed to meet all of its primary objectives.

This latest disappointing news came in the form of a company press release, which noted that “primary results from the Phase 3 ReThink-ALZ study of simufilam in mild-to-moderate AD did not meet any of the aforementioned studies.” , secondary and exploratory biomarker endpoints.”

The release went on to note that, after these results, Cassava decided to stop the planned Phase 3 testing of the drug.

Cassava Sciences (NASDAQ: SAVA ) stock fell 85% on Monday.

“The results are disappointing for patients and their families living with this disease and for doctors who have been searching for new treatments,” Cassava president and CEO Rick Barry said in a statement. “We have taken careful steps to enroll patients with mild to moderate AD. Despite that, cognitive loss in the placebo group was less significant than previously reported in other placebo-controlled studies in AD. We are working to better understand this.”

A series of problems and suspicions

The failure of this study comes after several government agencies called for Cassava methods. At the beginning of this year, Science reports that an FDA investigation found that City University of New York (CUNY) researcher Hou-Yan Wang, who was involved in the clinical trial of Cassava on simulfilam, used questionable data collection procedures.

Then, in June, Wang was indicted by the Department of Justice (DOJ) for allegedly “defrauding the National Institutes of Health (NIH) of approximately $16 million.” The DOJ release revealed that Wang participated in “a scheme to fabricate and falsify scientific information in grant applications made to the NIH on his behalf as well.” [Cassava Sciences].”

Wang has yet to comment on the case. We have contacted his attorney for comment.

Umdumbula said in a statement at the time that “Dr. Wang and his former university medical school were not involved in the Company’s Phase 3 clinical trials of simufilm.”

Then in September, Cassava and two of its former executives agreed to pay $40 million in a settlement with the SEC after the agency accused Cassava of “misleading statements made in September 2020 about the results of a Phase 2 clinical trial of the company’s intended treatment.” to treat Alzheimer’s disease.” The same SEC order also charged Wang with “falsifying reported clinical trial results.”

Vanderbilt University neuroscientist Matthew Schrag has previously blown the whistle on data and images that could be disputed by both Wang and Cassava.

In interview no Science this September, Schrag said, “There is strong evidence of corruption of the basic scientific and pharmaceutical data on which the phase 2 trial was based. Now, there is strong evidence of level 2 data corruption on which level 3 testing is based.”